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Clinical Research Associate (DU/FR/EN)

For one of our clients, a pharma company located in Wavre, we are looking for an experienced CRA to come on board and join the team. This rols is open to candidates with a previous experience in clinical research on the sponsor side, ideally as a CRA.

Job Description

As an experienced CRA, you will join our client's Real World Evidence team and will work on observational studies.

Responsibilities

  • Manage and prepare clinical study submissions to ethics committees together with CTA (Clinical Trial Assistant) and CPM (Clinical Project Manager)
  • Follow-up of Clinical Study Agreements (CSA) until its fully execution together with CTA and CPM
  • Prepare site files in collaboration with CTA
  • Conduct on site initiation and close-out visits with investigators and other related research personnel (e.g. research nurses) for the studies assigned.
  • During the study, follow-up with sites regarding inclusion, data entry, queries, data cleaning,…
  • Be the site's point of contact to answer study specific questions/resolve site issues.
  • Update internal KPI systems up to date for the assigned studies (event dates - site information - site reports)
  • Collecting, QC and filing of essential documents as defined per the company's SOPs for NIS
  • Budget / Payment tracking and execution of payments to Investigational sites staff as defined in the CSA (in collaboration with CTA)
  • Track and report site/study status to ARWEL/CPM.
  • Manage translation and tracking of translations for appropriate study documents if applicable.
  • Attend relevant internal and external training courses as determined by the line manager.

Requirements

  • Health related diploma (bachelor or master's degree)
  • Previous experience in clinical research on the sponsor side is mandatory, ideally as a CRA.
  • Ideally, trilingual DU/FR/EN or bilingual NL/EN or FR/EN with a good level in the other national
  • Proactive, problem-solver
  • Existing right to work in Europe is required

Benefits

  • A balanced salary package based on your skills and experience
  • Hybrid working policy : 3 days/week in the office and 2 days/week of homeworking
  • Permanent contract